Job Description

**General Description:** We are seeking a Clinical Biomarker Scientist to lead biomarker strategy and execution in clinical studies. The role involves designing and analyzing biomarker studies, collaborating with cross-functional teams, and managing external CROs to ensure high-quality data delivery. The ideal candidate will have a strong background in translational research, a deep understanding of clinical biomarkers, and excellent communication skills to drive insights that support clinical decision making and advance drug development. **Essential Functions of the job:** + Serve as the primary biomarker scientist for the clinical study team, ensuring biomarker strategies are integrated into clinical development plans. + Deliver robust biomarker strategies at the study level, including target engagement, pharmacodynamics endpoints, patient selection and companion diagnostic development (if appropriate). + Align biomarker strategies with clinical operational plans and functional area capabilities to ensure seamless execution. + Author and edit biomarker sections of clinical protocols, ensuring scientific accuracy and clarity. + Oversee the implementation of biomarker plans, including sample collection, alignment with consent forms, Human Biological Sample Management, and adherence to protocol and data standards. + Collaborate with and manage external vendors and collaborators involved in clinical studies or translational research, including vendor evaluation and selection for biomarker activities. + Evaluate and integrate emerging technologies into clinical studies, working closely with statisticians, bioinformatics teams, clinical and translational groups to address biomarker needs. + Lead the analysis and summarization of study specific biomarker data, presenting findings and strategic recommendations to internal and external stakeholders. + Stay informed on emerging scientific and technological advancement, contributing to the group's continuous improvement and innovation. **Qualifications:** + 3+ years of experience with PhD in Life Science (e.g., Immunology, Molecular & Cellular Biology, Biochemistry, or related fields), with a strong emphasis on immunology research and its application to translational science. + Demonstrated experience in clinical biomarkers and translational research in a pharmaceutical or biotech industry, particularly in Immunology, Oncology, or hematology. + Deep understanding of immunological mechanisms, immune-related biomarkers, and their role in clinical drug development. + Familiarity with the operational aspects of implementing biomarker strategies in clinical development is highly desirable. + Proven ability to collaborate within cross-functional, international teams and thrive in a fast-paced dynamic environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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